HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx only, Manufactured for
Summary
The FDA issued a Class II for HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syring by Samsung Bioepis Co., Ltd.. Reason: Lack of Assurance of Sterility..
Details
Source
Drug Recall
External ID
D-0099-2026
Action Date
2025-11-05
Status
Ongoing
Category
drug
Product Description
HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx only, Manufactured for: Organon LLC, a subsidiary of ORGANON & Co, Jersey City, NJ 07302, Manufactured by: SAMSUN BIOEPIS Co., Ltd, Incheon, Republic of Korea, NDC 78206-183-01.
Lot/Code Info: Lot: F2505017, Expiry: 24-Jan-2027
Quantity Affected: 5,518 packs (11,036 Syringes) 2 syringes/carton)
Reason for Recall
Lack of Assurance of Sterility.
Distribution
Distributed only to one warehouse in NJ. with no further distribution
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-10
Company
Yeonsu, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 95 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Samsung Bioepis Co., Ltd. has 5 FDA actions in our database, including 1 recall.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Samsung Bioepis Co., Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Samsung Bioepis Co., Ltd. have FDA actions?
Samsung Bioepis Co., Ltd. has 5 FDA actions in our database, including 1 recall and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0099-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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